FDA issues complete response letter for bimekizumab for plaque psoriasis

The FDA issued a complete response letter stating a biologics license application for bimekizumab cannot be approved until pre-approval inspection observations are resolved, according to a UCB press release.

UCB is working with the FDA to “address these observations as expeditiously as possible,” according to the release.

Bimekizumab is a treatment for adult patients with moderate to severe plaque psoriasis. It received marketing authorization in countries of the European Union and Great Britain in 2021 and in Japan, Canada and Australia in 2022.